Join a rapidly growing pharmaceutical company in Maryland as they expand in their brand new state-of-the-art facility. This position is responsible for managing all Quality Assurance (QA) activities, which fall under the QA Operations organization including drug substance and drug product release (clinical and commercial), stability data review, equipment, systems, and method validation documentation reviews, and contract manufacturing audits.
Responsibilities and Job Duties:
Establish and lead cross-functional teams to address operational issues relating to quality events, product release, equipment/system, utilities.
Review and Approve, Raw material and finished product lot release documents.
Maintain and communicate quality metrics to appropriate teams to ensure that product lots are released on time.
Implement QA Operations processes and procedures to ensure efficiency and compliance with regulations and guidance.
Applies risk management processes and principles and creates and utilizes risk analysis tools when assessing quality related issues
Review and approve deviations, change controls and other operational quality events.
Train QA Operations staff on review, evaluation, and risk assessment of quality events.
Develop the technical and bench knowledge of QA Operations staff to enable them to thoroughly assess quality events and associated risks.
Qualifies and maintains the qualification status of each vendor, contract manufacturer and contract testing laboratory.
Ensure that quality agreements with vendors, contract manufacturers and testing laboratories are up to date with business needs and quality content and are current.
Write, review, and approve QA SOPs supporting QA Operations responsibilities.
Prepares audit reports and communicates any critical or major issues to Head of Quality and Management.
A minimum of 10 years of experience in quality assurance or quality compliance
At least 2 years of experience in a life science GMP regulated manufacturing facility
A minimum of 2 years supervisory experience
Hands-on experience hosting and participating in regulatory inspections
Hands-on experience performing external quality audits
Hands-on experience writing comprehensive product investigations, audit reports, and SOPs
Knowledge, Skills and Abilities
Demonstrated knowledge, interpretation and application of US, EU and ICH GMP regulations and guidance.
Demonstrated knowledge and application of risk assessment tools
Excellent verbal and writing skills